BioLineRx achieves enrolment target in phase 3 GENESIS Trial for planned interim analysis

By 20/08/2020June 4th, 2021No Comments

BioLineRx announced that a sufficient number of patients (~65% of the original planned sample size) have been enrolled in the ongoing GENESIS Phase 3 trial to allow for an interim efficacy analysis to take place in the second half of 2020.

This ongoing registrational study is investigating motixafortide (BL-8040) for the mobilization of hematopoietic stem cells (HSCs) for autologous transplantation in patients with multiple myeloma. If the primary endpoint is met at the time of the interim analysis, the Company plans to immediately announce the cessation of further recruitment, without the need to enroll the full planned sample size. In this case, top-line results are expected in the first half of 2021, in order to maintain study blinding for all study endpoints, including those related to engraftment, for a period of 100 days subsequent to transplantation. If the primary endpoint is not reached in the interim analysis, the Company expects recruitment will continue until the originally planned sample size is met.

“A significantly lower than anticipated patient dropout rate in the GENESIS trial triggered our decision to conduct an interim efficacy analysis, for which we have now enrolled a sufficient number of patients,” said Philip Serlin, Chief Executive Officer of BioLineRx. “Once this analysis is complete, we will have enough information to decide whether to cease further enrollment or continue until completion of the original target enrollment of 177 patients. We expect the interim analysis to be completed within the next few months.”

The GENESIS trial was initiated in December 2017. GENESIS is a randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of motixafortide and G-CSF, compared to placebo and G-CSF, for the mobilization of HSCs for autologous transplantation in multiple myeloma patients.  The primary objective of the study is to demonstrate that motixafortide on top of G-CSF is superior to G-CSF alone in the ability of mobilize ≥ 6×106 CD34+ cells in up to two apheresis sessions. Secondary objectives include time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters.